Brief description of study

This study aims to answer very important questions regarding the prevalence of somatic and
germline mutations (sBRCAm and gBRCAm) in a population of newly diagnosed ovarian cancer
patients from Latin America. These answers may be extremely helpful in the counseling for
genetic risk and treatment approach in these populations and will aid in making treatment
decisions in the future

Detailed Study Description

FLABRA is a cross-sectional, multi-center, epidemiological observational study designed to
evaluate the prevalence of BRCA mutations in newly diagnosed ovarian cancer patients across
understudied ethnic groups in Latin America. Secondary objectives of the study are to
evaluate the prevalence of sBRCAm versus gBRCAm in newly diagnosed ovarian cancer patients
and to describe current ovarian cancer counselling and treatment approach patterns at front
line setting across Latin America.

In the Screening Visit, consecutive eligible patients who have been newly diagnosed with
ovarian cancer within the last 120 days will be invited to participate. After having provided
consent, patients will be asked to provide ethnicity and cancer family history information.
Patients will self-identify to one or more of the defined broad ethnic groups (Native
American, Afro-Caribbean, Caucasian) based on self-reported ancestry information. Archived
tumor blocks or twenty 10-m sections from eligible patients will be requested from the local
pathology lab and used for BRCA mutations testing.

Patient medical records will be reviewed for data relevant to the ovarian cancer diagnosis,
including basic demographics, medical history, and treatment history.

During the Devolution Visit, results of the tumor BRCA test will be communicated to the
patient, and information about counselling approach and treatment plan will be recorded in
the medical chart. This Devolution Visit will be the last visit for this study for the cases
of non-mutated patients. For patients for whom a BRCA mutation have been identified in tumor,
additional test in blood looking for the specific point mutation found in tumor will be
performed to investigate if these patients harbor a germline BRCA mutation. For these
patients a further visit will be organised to communicate results to the patient and data
regarding germline test results will be recorded in the medical chart of the patient.